Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

NCT02227212 | Completed Phase 3

• 3 other identifiers: PDY140652014-001253-16U1111-1155-7309
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

Primary Objective: To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300. Secondary Objectives: To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients. The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Ease-of-use / ease of learning questionnaire

  Day 1, Day 7 , 4-weeks

Secondary Outcomes (10)

• Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4

  Baseline, week 4

• Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4

  Baseline, week 4

• Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4

  Baseline, week 4

• Number of participants with Product Technical Complaints (PTC)

  Baseline to week 4

• Number of participants with adverse events and hypoglycemic events related to PTC

  Baseline to week 4

Study Arms (1)

Insulin glargine U300

EXPERIMENTAL

Once daily subcutaneous injection for 4 weeks

Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901

Interventions

Insulin glargine U300 (new formulation of insulin glargine) HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Insulin glargine U300

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate.
• Signed written informed consent.

You may not qualify if:

• Glycated hemoglobin A1c (HbA1c) \<7.0% (\<53 mmol/mol) or \>11% (97 mmol/mol) at screening.
• Age \<18 years at the time of screening.
• Body Mass Index (BMI) \>40 kg/m2.
• Diabetes other than T2DM.
• History of T2DM for less than 1 year before screening.
• Less than 6 months anti-hyperglycemic treatment before screening.
• Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
• Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
• Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
• Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
• Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
• Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling.
• More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Investigational Site Number 276011

Augsburg, 86150, Germany

Location

Investigational Site Number 276008

Berlin, 10115, Germany

Location

Investigational Site Number 276009

Essen, 45355, Germany

Location

Investigational Site Number 276002

Hamburg, 22607, Germany

Location

Investigational Site Number 276001

Münster, 48145, Germany

Location

Investigational Site Number 276007

Potsdam, 14469, Germany

Location

Investigational Site Number 276004

Wangen, 88239, Germany

Location

Related Publications (1)

• Pohlmeier H, Berard L, Brulle-Wohlhueter C, Wu J, Dahmen R, Nowotny I, Klonoff D. Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naive People With Type 2 Diabetes. J Diabetes Sci Technol. 2017 Mar;11(2):263-269. doi: 10.1177/1932296816668877. Epub 2016 Sep 25.

  PMID: 27664062 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (7)